EUCTR2006-002499-16-DEActive, not recruitingNot Applicable
Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.
Janssen R&D Ireland0 sitesStarted: August 29, 2006Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subject or Legal Authorized Representative has voluntarily given informed con-
- •sent before initiation of trial procedures.
- •2. Subject has documented HIV-1 infection.
- •3. Male or female subject over 18 years of age.
- •4. Subject has limited treatment options due to virological failure or intolerance to
- •multiple ARV regimens.
- •5. Subject is at least 3-class experienced (3 classes of licensed oral ARVs: N[t]RTIs,
- •PIs, NNRTIs).
- •Note: Subjects with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria.
- •6. Subject has previously received 2 different PI-based regimens.
- •7. Subject is unable to use currently approved NNRTIs due to resistance (primary or
- •acquired) and/or intolerance.
- •8. Subject, if currently receiving an ARV regimen, is not achieving adequate virologic
- •suppression on his/her current regimen (defined as a confirmed detectable
- •plasma VL on the current treatment).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Primary HIV infection.
- •2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
- •3. Any condition which, in the opinion of the investigator, could compromise the sub-
- •ject’s safety or adherence to the protocol.
- •4. Use of disallowed concomitant therapy, including disallowed ARVs.
- •5. Use of non-ARV investigational medications within the 30 days prior to baseline
- •6. Use of investigational ARVs, unless stated as an exception in Section 5.3.8.2.2 of
- •the protocol.
- •7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis,
- •acute viral infection) or findings during screening of medical history or physical
- •examination that is not either resolved or stabilized for at least 30 days before
- •the screening phase of the trial.
- •8. Acute viral hepatitis, including but not restricted to A, B or C.
- •9. Pregnant or breast-feeding female.
- •10. Female subject of childbearing potential not using effective non-hormonal birth
- •control methods or not willing to continue practicing these birth control methods
- •from screening until the last trial related activity.
- •Note: Hormone based contraception may not be reliable when taking TMC125; therefore, to be eligible for this trial, women of childbearing potential who may have vaginal intercourse should either:
- •(1) Use a double barrier method to prevent pregnancy (i.e., use a condom without
- •spermicide, with either a diaphragm or cervical cap) or
- •(2) Use hormone based contraceptives in combination with a barrier contraceptive
- •(i.e., male condom without spermicide, diaphragm or cervical cap or female
- •(3) Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e.,
- •male condom without spermicide, diaphragm or cervical cap or female condom) or
- •Note: The use of an IUD has been associated with an increased rate of sexually
- •transmitted diseases.
- •(4) Be non-heterosexually active, practice sexual abstinence or have a vasectomized
- •partner (confirmed sterile).
- •Note: Women who are postmenopausal for at least 2 years, women with total
- •hysterectomy and women with tubal ligation are considered of nonchildbearing
- •11. Subjects with the following laboratory abnormalities as defined by a standard-
- •ized grading scheme based on the Division of AIDS (DAIDS) grading table (up-
- •dated version from December 2004, see Section 7.2):
- •- Hemoglobin < 7,4 g/dL (4,5 mmol/L)
- •- Absolute neutrophil count < 500/mm³ (0,5 x 10 9/l)
- •- Platelets < 25 000/mm3 (25 000 x 10 9/l)
- •- Prothrombin time (PT) >1,5 x upper limit of laboratory normal range (ULN)
- •Note: Subjects on anticoagulant therapy with elevated PT > 1,5 ULN require approval of the sponsor prior to enrollment.
- •- Alkaline phosphatase > 5 x ULN
- •- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 5 x ULN
- •- Bilirubin > 5 x ULN
- •Note: Subjects with elevated bilirubin > 5xULN assessed as related to a component
- •of ART therapy may be enrolled with prior approval of the sponsor.
- •- Lipase > 3 x ULN
- •- Amylase > 5 x ULN if lipase > 2 x ULN
- •- Creatinine > 1,8 x ULN
- •12. Subjects with clinical or laboratory evidence of significantly decreased hepatic
- •function or decompensation, irrespective of liver enzyme levels.
- •Note: Subje
Investigators
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